TEL AVIV, Israel, March 18, 2019 /PRNewswire/ -- Cellect
Biotechnology Ltd. (NASDAQ: APOP), a developer of a novel stem cell
production technology, today announced operating and financial
results for the fourth quarter and full year ended December 31, 2018, as well as recent corporate
progress.
"We made progress in 2018 as we overcame the short-term setback
of patient recruitment in our trial in Israel and moved closer to the initiation of
our U.S. clinical efforts," commented Dr. Shai Yarkoni, Chief Executive Officer. "We
continue to validate our innovative science, and the U.S. Food and
Drug Administration's (FDA) recent decision to hire at least 50
clinical assesors to focus on cell and gene therapy companies is
precisely why we believe Cellect will be a major beneficiary in the
growth of this sector – companies and academics need to source stem
cells from a reliable and cost effective supplier to develop their
therapies over the next decade and we are positioning Cellect's
technology to enable that. Operationally, we recently strengthened
our balance sheet through an underwritten public offering, securing
interest from sophisticated healthcare investors and participation
from senior executives from Cellect, which reflects our continued
optimism and outlook for 2019. We look forward to providing an
update on our progress in the coming months through a business
update conference call."
Recent Operating and Financial Highlights:
- Validated through an independent third party that the ApoGraft
technology accelerates mesenchymal stem cell (MSC) expansion
relative to processes currently used in research and
manufacturing.
- Concluded the scale-up development and manufacturing of
clinical grade FasL in collaboration with its outsourced supplier,
enabling the Company to expedite U.S. clinical programs into
multiple studies.
- Entered into a collaboration with Washington University, a leading academic
institution based in St. Louis,
MO, to determine the safety and tolerability in a U.S. Phase
I/II study using ApoGraft™ for bone marrow transplantations.
- Strengthened the balance sheet through a $6.5 million underwritten public offering,
providing the Company additional resources to execute its business
strategy.
Anticipated Near-Term Milestones:
- The Company expects the Investigational New Drug (IND)
application to be submitted to the FDA by the lead investigator,
Dr. John DiPersio, Director of the
Center for Gene and Cellular Immunotherapy at Washington University School of Medicine and
President of the American Society for Blood and Marrow
Transplantation, in the second quarter of 2019.
- The Company expects to report interim data from the Israeli
trial in the second quarter of 2019.
Key 2018 Achievements:
Clinical Results in Israel
Continue to Validate the Company's Innovation
- Reported the results of the first six patients after a one
month follow-up in the clinical trial of Cellect's ApoGraft™ stem
cell transplant with 100% acceptance and zero related adverse
events.
- Opened a second clinical trial site at Hadassah Medical Center
and received the approval from the Data and Safety Monitoring Board
(DSMB) for dose escalation in the third of the fourth cohort in the
clinical trial.
- Successfully completed the proof of concept testing of the
Company's ApoTainer™ using its FasL-coated magnetic beads for
maximizing efficacy and scalability of stem cell based products'
manufacturing. The ApoTainer™ is designed to replace high risk,
complex and expensive procedures currently used by laboratories
(e.g. T cells depeletion), with a significantly more effective
process at a fraction of the time and cost.
Corporate Development Initiatives to Drive Commercialization
Efforts
- Launched a U.S. subsidiary (Cellect Biotech, Inc.) to oversee
business and clinical development efforts in the U.S. market.
Key Collaboration Agreements
- Signed a collaboration and material transfer agreement with the
denovoMATRIX group of the Technische Universität Dresden (TU
Dresden), a leading center for stem cell research in Germany.
- Finalized a strategic manufacturing and supply agreement with
Swiss Biotech Center (SBC) to secure production of FasL protein -
Cellect's main active ingredient in ApoGraft™ and the ApoTainerTM
for planned clinical trials in the U.S.
- Entered into a collaboration agreement with Cell2in, a South
Korean company focused on improving the quality of cells. According
to the agreement, the companies will conduct scientific evaluations
combining Cellect's technology platform ApoGraft™ with Cell2in's
proprietary identification technology FreSHtracer™ which monitors
stem cell quality by utilizing a fluorescent dye to characterize
their oxidative stress state.
Protecting and Enhancing the Company's IP Portfolio
- Granted a patent by the European Patent Office Company for its
ApoTainer™ device, which is used in conjunction with its platform
ApoGraft™ technology titled, "Devices and Methods for
Selecting Apoptosis-Signaling Resistant Cells, and Uses Thereof"
and received a Notice of Allowance from the Korean Intellectual
Property Office and the Japanese and Australian Offices for
Patents & Trademarks for the same patent.
- Two new patent applications were submitted during 2018
covering further propriatory inventions in connection with
mesenchymal stem cells and CAR-T cells expansion processes.
Fourth Quarter and Full Year 2018 Financial Results:
- Research and development (R&D) expenses for the
fourth quarter and for the full year of 2018 were $1.08 million and $3.60
million respectively, compared to $0.91 million in the fourth quarter of 2017 and
$3.07 million for the full year of
2017. The increase in R&D expenses for the full year of 2018 as
compared to the full year of 2017 was primarily due to an increase
from purchasing materials and an increase in salaries and related
expenses reflecting the progress in our research and development
activities and the growth of our employees working on our research
and development activities.
- General and administrative (G&A) expenses for the fourth
quarter and for the full year of 2018 were $1.26 million and $4.20
million respectively, compared to $0.91 million in the fourth quarter of 2017 and
$3.45 million for the full year of
2017. The increase in G&A expenses for the full year of 2018 as
compared to the full year of 2017 was primarily due to increase in
salaries and related personnel expenses due to an increase in the
number of our business development personnel.
- Finance income for the fourth quarter and for the full year of
2018 was $1.34 million, and $2.44
million respectively, compared to $0.92 million in the fourth quarter of 2017 and
expenses of $1.01 million for the
full year of 2017 respectively. The financial income in the full
year of 2018 as compared to the expenses in the full year of 2017,
is primarily due to the change in the fair value of the listed
warrants granted in our U.S. initial public offering in 2016 and of
the unregistered warrants granted in our registered direct
offerings in 2017 and in 2018.
- Total Comprehensive loss for the fourth quarter and for the
full year of 2018 was $1.00 million and $5.37 million respectively, or $0.008 per share for the fourth quarter and
$0.041 per share for the year of 2018
respectively, compared to $0.90
million, or $0.007 per share,
in the fourth quarter of 2017 and $7.53
million, or $0.067 per share
for the full year of 2017.
Balance Sheet Highlights:
- Cash and cash equivalents and marketable securities totaled
$4.75 million as of December 31, 2018, compared to $6.24 million on September
30, 2018, and $7.40 million on
December 31, 2017. The change
compared to December 31, 2017 was
primarily due to a net proceeds of $3.6M in a registered direct offering in
January 2018, offset by ongoing
operational expenses.
- Shareholders' equity totaled $3.71
million as of December 31,
2018, compared to $4.37
million on September 30, 2018,
and $5.03 million on December 31, 2017.
For the convenience of the reader, the amounts have been
translated from NIS into U.S. dollars, at the representative rate
of exchange on December 31, 2018
(U.S. $1 = NIS
3.748).
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: APOP) has developed a
breakthrough technology, for the selection of stem cells from any
given tissue, that aims to improve a variety of stem cell-based
therapies.
The Company's technology is expected to provide researchers,
clinical community and pharma companies with the tools to rapidly
isolate stem cells in quantity and quality allowing stem cell-based
treatments and procedures in a wide variety of applications in
regenerative medicine. The Company's current clinical trial is
aimed at bone marrow transplantations in cancer treatment.
Forward Looking Statements
This press release contains forward-looking statements about the
Company's expectations, beliefs and intentions. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe", "expect", "intend", "plan", "may", "should",
"could", "might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. For
example, forward-looking statements are used in this press release
when we discuss Cellect's intent regarding the future potential of
Cellect's technology. These forward-looking statements and their
implications are based on the current expectations of the
management of the Company only and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
In addition, historical results or conclusions from scientific
research and clinical studies do not guarantee that future results
would suggest similar conclusions or that historical results
referred to herein would be interpreted similarly in light of
additional research or otherwise. The following factors, among
others, could cause actual results to differ materially from those
described in the forward-looking statements: the Company's history
of losses and needs for additional capital to fund its operations
and its inability to obtain additional capital on acceptable terms,
or at all; the Company's ability to continue as a going concern;
uncertainties of cash flows and inability to meet working capital
needs; the Company's ability to obtain regulatory approvals; the
Company's ability to obtain favorable pre-clinical and clinical
trial results; the Company's technology may not be validated and
its methods may not be accepted by the scientific community;
difficulties enrolling patients in the Company's clinical trials;
the ability to timely source adequate supply of FasL; risks
resulting from unforeseen side effects; the Company's ability to
establish and maintain strategic partnerships and other corporate
collaborations; the scope of protection the Company is able to
establish and maintain for intellectual property rights and its
ability to operate its business without infringing the intellectual
property rights of others; competitive companies, technologies and
the Company's industry; unforeseen scientific difficulties may
develop with the Company's technology; and the Company's ability to
retain or attract key employees whose knowledge is essential to the
development of its products. Any forward-looking statement in this
press release speaks only as of the date of this press release. The
Company undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual
Report on Form 20-F for the fiscal year ended December 31, 2018 filed with the U.S. Securities
and Exchange Commission, or SEC, which is available on the SEC's
website, www.sec.gov, and in the Company's periodic filings with
the SEC.
Cellect Biotechnology
Ltd
|
Consolidated
Statement of Operation
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
|
|
Twelve
months
ended
|
|
Twelve months
ended
|
|
Three months
ended
|
|
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
Unaudited
|
|
Audited
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
U.S.
dollars
|
|
NIS
|
|
|
(In thousands,
except share and per
share
data)
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
3,605
|
|
13,513
|
|
11,503
|
|
4,040
|
|
3,404
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
4,198
|
|
15,734
|
|
12,930
|
|
4,733
|
|
3,406
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
7,803
|
|
29,247
|
|
24,433
|
|
8,773
|
|
6,810
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income) due to
warrants exercisable into ADS
|
|
(2,059)
|
|
(7,719)
|
|
3,208
|
|
(4,784)
|
|
(3,614)
|
|
|
|
|
|
|
|
|
|
|
|
Other financial
expenses (income), net
|
|
(377)
|
|
(1,415)
|
|
583
|
|
(238)
|
|
172
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
5,367
|
|
20,113
|
|
28,224
|
|
3,751
|
|
3,368
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
0.041
|
|
0.155
|
|
0.252
|
|
0.029
|
|
0.028
|
Basic and diluted loss
per ADS
|
|
0.82
|
|
3.11
|
|
5.04
|
|
0.58
|
|
0.56
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares
outstanding used to compute basic and
diluted loss per share
|
|
129,426,091
|
|
129,426,091
|
|
111,968,663
|
|
130,274,953
|
|
120,011,684
|
Cellect Biotechnology
Ltd
|
Consolidated Balance
Sheet Data
|
ASSETS
|
|
Convenience
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2018
|
|
2017
|
|
|
Unudited
|
|
Audited
|
|
Audited
|
|
|
U.S.
dollars
|
|
NIS
|
|
|
(In thousands,
except share and per
share
data)
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
4,752
|
|
17,809
|
|
13,734
|
|
Marketable
securities
|
-
|
|
-
|
|
13,999
|
|
Other
receivables
|
218
|
|
816
|
|
818
|
|
|
|
|
|
|
|
|
|
4,970
|
|
18,625
|
|
28,551
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
Restricted
cash
|
90
|
|
337
|
|
305
|
|
Other long-term
assets
|
35
|
|
132
|
|
173
|
|
Property, plant and
equipment, net
|
412
|
|
1,544
|
|
1,344
|
|
|
|
|
|
|
|
|
|
537
|
|
2,013
|
|
1,822
|
|
|
|
|
|
|
|
|
|
5,507
|
|
20,638
|
|
30,373
|
|
LIABILITIES
AND
SHAREHOLDERS'
EQUITY
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Trade
payables
|
237
|
|
887
|
|
1,703
|
|
Other
payables
|
1,070
|
|
4,012
|
|
2,396
|
|
|
1,307
|
|
4,899
|
|
4,099
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Warrants to
ADS
|
485
|
|
1,816
|
|
7,422
|
|
|
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
|
|
Ordinary shares of no
par value:
Authorized:
500,000,000 shares at December 31, 2017 a
nd December 31 2018; Issued and outstanding:
120,185,659*) and 130,414,799*) shares as of
December 31, 2017 and December 31, 2018,
respectively.
|
-
|
|
-
|
|
-
|
|
Additional Paid In
Capital
|
25,370
|
|
95,085
|
|
82,839
|
|
Share-based
payments
|
3,287
|
|
12,319
|
|
9,381
|
|
Treasury
shares
|
(2,515)
|
|
(9,425)
|
|
(9,425)
|
|
Accumulated
deficit
|
(22,427)
|
|
(84,056)
|
|
(63,943)
|
|
|
|
|
|
|
|
|
|
3,715
|
|
13,923
|
|
18,852
|
|
|
|
|
|
|
|
|
|
5,507
|
|
20,638
|
|
30,373
|
|
*)
Net of 2,641,693 treasury shares of the Company held by the
Company.
|
|
Cellect Biotechnology
Ltd
|
Consolidated Cash
Flow Data
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
|
|
|
Twelve
months
ended
|
Twelve months
ended
|
|
Three months
ended
|
|
|
|
December
31,
|
December
31,
|
|
December
31,
|
|
|
|
2018
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
Unaudited
|
Audited
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
U.S.
dollars
|
NIS
|
|
|
|
(In
thousands)
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(5,367)
|
(20,113)
|
|
(28,224)
|
|
(3,751)
|
|
(3,368)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net
cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Exchange rate
difference
|
|
(345)
|
(1,297)
|
|
532
|
|
(380)
|
|
175
|
|
Loss (gain) from
revaluation of financial
assets presented at fair value through
profit and loss
|
|
(106)
|
(397)
|
|
139
|
|
(109)
|
|
(1)
|
|
Depreciation
|
|
122
|
459
|
|
372
|
|
122
|
|
94
|
|
Changes in fair value
of traded and non
traded warrants to ADS
|
|
(2,059)
|
(7,719)
|
|
3,003
|
|
(4,511)
|
|
1,368
|
|
Share-based
payment
|
|
1,210
|
4,537
|
|
5,384
|
|
1,290
|
|
(3,647)
|
|
Decrease (increase) in
other receivables
|
|
12
|
43
|
|
470
|
|
(214)
|
|
107
|
|
Increase (decrease) in
other payables
|
|
213
|
798
|
|
407
|
|
1,505
|
|
1,040
|
|
Interest
received
|
|
14
|
54
|
|
147
|
|
7
|
|
-
|
|
Net cash used in
operating activities
|
|
(6,306)
|
(23,635)
|
|
(17,770)
|
|
(6,041)
|
|
(4,232)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
|
|
Short term deposits,
net
|
|
103
|
387
|
|
19,530
|
|
105
|
|
-
|
|
Restricted deposit,
net
|
|
(6)
|
(22)
|
|
(165)
|
|
-
|
|
2
|
|
(Purchase) Sales of
marketable securities measured
at fair value through profit and loss
|
|
3,735
|
13,999
|
|
(9,008)
|
|
-
|
|
(4,001)
|
|
Purchase of property,
plant and equipment
|
|
(175)
|
(656)
|
|
(266)
|
|
(13)
|
|
(91)
|
|
Net cash provided by
investing activities
|
|
3,657
|
13,708
|
|
10,091
|
|
92
|
|
(4,090)
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
and stock options into shares
|
|
106
|
399
|
|
1,432
|
|
-
|
|
169
|
|
Issue of share capital
and warrants, net of issue costs
|
|
3,299
|
12,360
|
|
14,381
|
|
-
|
|
(510)
|
|
Net cash provided
(used) by financing activities
|
|
3,405
|
12,759
|
|
15,813
|
|
-
|
|
(341)
|
|
Exchange differences on
balances of cash and cash equivalents
|
|
332
|
1,243
|
|
(679)
|
|
373
|
|
(175)
|
|
Increase (decrease) in
cash and cash equivalents
|
|
1,088
|
4,075
|
|
7,455
|
|
(5,576)
|
|
(8,838)
|
|
Balance of cash and
cash equivalents at the beginning of the period
|
|
3,664
|
13,734
|
|
6,279
|
|
23,385
|
|
22,572
|
|
Balance of cash and
cash equivalents at the end of the period
|
|
4,752
|
17,809
|
|
13,734
|
|
17,809
|
|
13,734
|
|
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou / Todd Kehrli
+1(732) 933-2754
mpolyviou@evcgroup.com / tkehrli@evcgroup.com
View original
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SOURCE Cellect Biotechnology Ltd.